Study of 400mcg Versus 800mcg Buccal Misoprostol Following Mifepristone 200mg for Abortion up to 63 Days Gestation

Gynuity Health Projects1,220 enrolled

Overview

This double-blind, randomized study will compare the efficacy and acceptability of mifepristone 200mg followed in 36-48 hours by 400mcg or 800mcg of buccal misoprostol (i.e., in the cheeks) for termination of pregnancy in women up to 63 days LMP.

The goal of this study is to provide answers to the following four questions: 1. Is a regimen of medical abortion with mifepristone using 400mcg buccal misoprostol as effective and acceptable as using 800mcg buccal misoprostol up to 63 days since the last menstrual period (LMP)? 2. Are the side effects with buccal use tolerable for women? 3. Is buccal administration of misoprostol acceptable to women? 4. When given a choice, do women prefer to take misoprostol at home or in the clinic?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,220

Conditions

Induced Abortion

Interventions

Mifepristone, misoprostolDRUG

200mg mifepristone followed by 400mcg misoprostol 36-48 hours later

mifepristone, misoprostolDRUG

200mg mifepristone followed by 800mcg misoprostol 36-48 hours later

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Women 18 years or over presenting for abortion services who consent to participate * good general health * assessed by a clinician to have an intrauterine pregnancy less than 64 days LMP on Study Day 1 and to be eligible for medical abortion * Have ready access to a telephone and emergency transportation; * Be willing to provide an address and/or telephone number for purposes of follow-up Exclusion Criteria: * Conditions which contraindicate the use of mifepristone or misoprostol * Women presenting for medical abortion who do not consent to participate

Locations (4)

Maternity House #2

Tbilisi, Georgia

Maternity House #4

Tbilisi, Georgia

Zhordania Institute of Human Reproduction

Tbilisi, Georgia

Hocmon Hospital

Ho Chi Minh City, Vietnam

Outcomes

Primary Outcomes

Need for surgical completion for ongoing viable pregnancies at follow up visit (Study day 12-15) or for incomplete abortion at extended follow up visit (Study day (19-22).

Time frame: Study day 12-15 for ongoing viable pregnancies or Study day 19-22 for incomplete abortion at extended follow up visit

Secondary Outcomes

Side-effects, acceptability for women

Time frame: side effects and acceptability recorded at exit interview

Data from ClinicalTrials.gov

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